FDA OKs Miach Ortho’s BEAR Implant Labeling for Lower PTOA Risk

Miach Orthopedics revealed that it earned U.S. Food and Drug Administration (FDA) 510(k) clearance for updated labeling to its BEAR (Bridge-Enhanced ACL Restoration) implant.

The agency nod means the implant’s labeling now includes a reduced risk of developing radiographically confirmed post-traumatic osteoarthritis (PTOA) following ACL injury compared to ACL reconstruction using hamstring tendon autograft. The BEAR Implant is the first sports medicine product to include a label claim associated with PTOA risk, according to Miach.

PTOA is a progressive disease that can arise in the years after an ACL injury. Studies show rates of clinically symptomatic PTOA as high as 50% for patients who have their ACL reconstructed, Miach said.

Early PTOA symptoms might include knee pain, stiffness, swelling, or loss of function—these can worsen over time and interfere with daily life and athletics. There’s not presently a cure other than total knee replacement and current treatments manage symptoms instead of restoring a healthy joint.

“For decades, we’ve focused on restoring knee stability with ACL reconstruction, while largely accepting post-traumatic osteoarthritis as an unavoidable future tradeoff,” said Gregory DiFelice, MD, strategic advisor for Miach Orthopaedics. “The simple reason is because there were never other reasonable options to stabilize the knee following an ACL tear beyond reconstruction. Until now. Data from the BEAR I and II studies clearly demonstrate that patients 14 and older treated with an ACL reconstruction are significantly more likely to develop post-traumatic osteoarthritis than those undergoing a BEAR Implant procedure. The risk of post-traumatic arthritis should be part of every ACL treatment discussion so that patients and parents can understand how different surgical treatment options impact the long-term health of the knee, not just short-term recovery.”

The six-year pooled BEAR studies, which formed the basis of the label update, assessed the rate of radiographically confirmed PTOA following the BEAR procedure compared with ACL reconstruction (using mainly hamstring autograft) in patients ages 14 and older with concomitant baseline knee injuries, such as a meniscus tear.

Patients treated with ACL reconstruction had a rate of PTOA six times higher than patients treated with the BEAR Implant. The reduction in six-year PTOA for BEAR Implant patients compared to ACLR was statistically significant (–27.7%, p=0.002), reinforcing long-term knee health as an important outcome for ACL surgery beyond short-term stability and return to play.

“Today is a defining moment in ACL tear treatment,” said Patrick McBrayer, president and CEO of Miach Orthopaedics. “Pre-clinical BEAR Implant research suggested that preserving the native ACL could reduce the risk of post-traumatic osteoarthritis. This label update is a validation of the long-term clinical data displaying an unprecedented benefit in a FDA cleared claim, setting a new bar for what patients and clinicians should expect from ACL treatment and reinforcing the potential for the BEAR Implant to change the trajectory of knee health after ACL injury.”

In March 2025, the BEAR implant won FDA clearance to expand use to children and adolescents of any age, as well as to treat partial anterior cruciate ligament (ACL) tears.